Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
研究概览
简要总结
This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy
详细描述
Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure.
Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically suspected/confirmed CBDS
- •CBD caliber 5-15 mm
排除标准
- •History of bile duct surgery
- •History of bile duct tumor
- •History of bile duct stricture
- •Severe comorbidity
- •Unstable vital signs
- •Pregnancy
- •Coagulopathy
结局指标
主要结局
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
时间窗: 1 year
次要结局
- Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal(1 year)
研究者
Thanawat Luangsukrerk
Gastrointestinal Endoscopy Excellence Center
Chulalongkorn University
